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Biotechnology
The US Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for the investigation Pompe disease drug cipaglucosidase alfa, the biologic component of AT-GAA, US biotech Amicus Therapeutics announced on Friday. 31 October 2022
Biotechnology
US biopharma PTC Therapeutics has entered into a strategic financing collaboration with funds managed by Blackstone. 28 October 2022
Pharmaceutical
German drug major Bayer’s Kerendia (finerenone), a first-in-class, non-steroidal mineralocorticoid receptor antagonist (ns-MRA), was recommended as part of a comprehensive treatment strategy for patients with chronic kidney disease (CKD) associated with type 2 diabetes. 28 October 2022
Pharmaceutical
British firm PhoreMost has entered into a multi-target collaboration with Arvinas, a Connecticut, USA-basesd specialist in targeted protein degradation. 28 October 2022
Biotechnology
Swiss drugmaker Roche has revealed new long-term data for Ocrevus (ocrelizumab), related to disease progression and healthcare costs in people with early-stage relapsing-remitting multiple sclerosis (RRMS). 27 October 2022
Biotechnology
Taiwan biotech OrientPharma (OEP) has signed an exclusive agreement with the Italian rare disease drug developer Chiesi to bring two drugs and one clinical stage candidate to Taiwan and Southeast Asian countries. 27 October 2022
Biotechnology
UK immunotherapy company Scancell Holdings has announced that John Chiplin intends to resign his role as executive chairman and non-executive director of the company for personal reasons. 26 October 2022
Biotechnology
Australian clinical-stage biotech Immutep today announced that the Independent Data Monitoring Committee (IDMC) for the randomized, controlled Phase IIb TACTI-003 trial has reviewed initial safety data and recommended continuing the trial with no modifications. 26 October 2022
Pharmaceutical
Symeres, a Netherlands-based contract research organization (CRO) and contract development manufacturing organization, has acquired Exemplify BioPharma, a USA-based CRO. 25 October 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has today announced its decision to postpone the planned Endocrinologic and Metabolic Drugs Advisory Committee meeting for investigational palovarotene until a later date to be confirmed, says the drug’s developer, French drugmaker Ipsen. 25 October 2022
Biotechnology
Asia-Pacific-focused contract research organization (CRO) Novotech has commissioned a report for biotechs considering China for their clinical research. 25 October 2022
Pharmaceutical
Swiss vaccines company LimmaTech Biologics has announced a license and collaboration agreement with Griffith University in Queensland, Australia. 24 October 2022
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The US Food and Drug Administration (FDA) has granted pediatric exclusivity for Regeneron Pharmaceuticals’ Eylea (aflibercept) Injection. 24 October 2022
Pharmaceutical
British psychedelic medicines specialist Beckley Psytech is to acquire clinical-stage life science company, Eleusis Therapeutics, for an undisclosed sum. 24 October 2022
Biotechnology
US pharma giant Pfizer indicted it will increase the US price of its COVID-19 vaccine Comirnaty to about $110 to $130 per dose after the US government's current purchase program expires, the firm’s executive Angela Lukin said on Thursday, according to a report by Investing.com. 21 October 2022
Biotechnology
US biotech major Gilead Sciences today revealed that its Kite subsidiary has entered into an exclusive, worldwide license agreement with Refuge Biotechnologies, a synthetic biology company for cancer immunotherapy, for exclusive rights to utilize Refuge’s proprietary gene expression platform to develop potential treatments for blood cancers. 20 October 2022
Pharmaceutical
A collaboration has been forged between British early-stage research firm C4X Discovery (C4XD) and Shanghai-based DNA specialist HitGen. 20 October 2022
Pharmaceutical
New data is to be presented by Shionogi on its approved antibiotic Fetroja (cefiderocol) at IDWeek 2022, including new real-world evidence demonstrating the drug’s strong efficacy against some of the most difficult-to-treat gram-negative bacterial infections. 19 October 2022
Pharmaceutical
Irish ophthalmic and active pharmaceutical ingredient (API) specialist C2 Pharma has announced plans to expand its API product portfolio. 19 October 2022
Pharmaceutical
Boston, Massachusetts-based Ikena Oncology has announced a clinical trial collaboration with AstraZeneca, for the evaluation of Tagrisso (osimertinib), together with its lead candidate, in EGFR-mutated non-small cell lung cancer (NSCLC). 18 October 2022
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Biotechnology
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Biotechnology
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
Biotechnology
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
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The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
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